Arthritis Pain Relief

Description

Acetaminophen Extended-Release Tablets, USP, contain 650 mg of acetaminophen per tablet. These gelatin-coated tablets are formulated as a pain reliever and fever reducer, specifically indicated for the temporary relief of minor arthritis pain. The extended-release formulation provides therapeutic effects that last up to 8 hours. Each bottle contains 80 geltabs.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, and toothache. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults are advised to take 2 geltabs every 8 hours, ensuring that only one geltab is swallowed at a time. Prior to swallowing each geltab, it is recommended to take a sip of water, and each geltab should be washed down with water, up to a full 8 oz. glass. Geltabs must be swallowed whole and should not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 geltabs within a 24-hour period. Additionally, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional.

For individuals under 18 years of age, it is essential to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients with difficulty swallowing large tablets or capsules, as this may lead to choking or inadequate dosing. This is particularly relevant for individuals over the age of 65, who may experience increased difficulty.

• In individuals with a known allergy to acetaminophen or any of the inactive ingredients present in this formulation, as this may result in allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 6 geltabs within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

It is essential to consult a healthcare provider prior to use in patients with liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as interactions may occur.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should also be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain or pain lasting more than 10 days, worsening fever or fever lasting more than 3 days, the emergence of new symptoms, presence of redness or swelling, or if the tablet becomes lodged in the throat. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if patients exceed the maximum daily dosage of six geltabs within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than three days, if new symptoms arise, if redness or swelling is observed, or if the tablet becomes lodged in the throat, as these may indicate a serious condition.

It is recommended that patients consult a doctor prior to use if they have liver disease. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before using this product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Arthritis Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 18 years of age should consult a healthcare professional prior to use. It is essential to assess the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients, particularly those aged 65 and older, may experience difficulty swallowing the tablets. It is important for healthcare providers to consider this when prescribing the medication to geriatric patients, as alternative formulations may be necessary to ensure proper administration.

Additionally, it is advised that elderly patients consult with a healthcare professional prior to use if they have a history of liver disease. This precaution is essential to mitigate potential risks associated with hepatic impairment, which may affect drug metabolism and increase the likelihood of adverse effects.

Furthermore, prompt medical attention is crucial for elderly patients, as well as for children, even in the absence of noticeable signs or symptoms. Healthcare providers should emphasize the importance of monitoring for any changes in health status and ensure that caregivers are aware of the need for immediate evaluation in case of any concerns.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert, as there is no information regarding dosage adjustments, special monitoring, or safety considerations for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 6 geltabs within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications arising from the overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, reports indicate the importance of prompt medical intervention in cases of overdose. Individuals are urged to contact a Poison Control Center or seek medical help without delay, as timely attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a container that features a tamper-evident seal. It is essential to refrain from using the product if the imprinted seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20 to 25° C (68 to 77° F). It is important to avoid exposure to high humidity conditions to ensure the integrity of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with adults advised to take 2 geltabs every 8 hours. Each geltab should be swallowed whole, without crushing, chewing, splitting, or dissolving, and should be taken with a sip of water before swallowing, followed by a full glass of water. The maximum dosage is 6 geltabs within a 24-hour period, and use should not exceed 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor before use if they have liver disease or are taking the blood thinner warfarin. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

This file contains official product information for Arthritis Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)